A Double Blind Crossover Trial of Levetiracetam (Keppra®) and Placebo in the Treatment of Restless Legs Syndrome (RLS)

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1:To investigate the efficacy of levetiracetam when used to treat RLS.

2:To assess tolerability and adverse event rates.

Original Primary Outcome Measures ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ICMJE

Not Provided

Original Secondary Outcome Measures ICMJE

Not Provided

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

A Double Blind Crossover Trial of Levetiracetam (Keppra®) and Placebo in the Treatment of Restless Legs Syndrome (RLS)

Official Title ICMJE

A Double Blind Crossover Trial of Levetiracetam (Keppra®) and Placebo in the Treatment of Restless Legs Syndrome (RLS)

Brief Summary

To define the effective dose and tolerability of levetiracetam in individuals with Restless Legs Syndrome (RLS). It is hypothesized that levetiracetam will be well tolerated, safe and effective in treating the symptoms of RLS.

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

20

Estimated Completion Date

October 2005

Primary Completion Date

Not Provided

Eligibility Criteria ICMJE

Inclusion Criteria:

Diagnosed with idiopathic RLS according to the four IRLSSG diagnostic criteria

An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.

The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as sitting or lying down.

The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues

The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night.

IRLS Rating Scale score greater than 15 at Baseline visit PLM-Index of 5 or greater during the first night of polysomnography Written informed consent obtained prior to any study procedures being performed.

Exclusion Criteria:

Women of childbearing potential, who have a positive urine pregnancy test or are lactating as the screening visit, or do not practice a clinically accepted method of contraception.

Individuals who are taking medication for Restless Legs Syndrome without a proper washout period

Individuals who are taking hypnotics, sedatives, antipsychotics, or neuroleptics

History of current diagnosis of other clinically relevant diseases that may confound assessments of RLS symptoms (e.g., Parkinson’s disease, dementia, ALS, etc.)

Subjects with an apnea/hypopnea index of 15 or greater at the initial polysomnography visit

Subjects employed in shift work (e.g., employment hours disruptive to the normal circadian sleep-wake cycle such as nighttime or variable rotating shifts)

Subjects who have clinically significant or unstable medical conditions which in the opinion of the investigator would render the subject unsuitable for the study (e.g. severe cardiovascular disease, major depression, psychosis, hepatic or renal failure, etc.)